• AGI Therapeutics plc, of Dublin, Ireland, reported positive results of a clinical study to assess the pharmacokinetic profile of Rezular (AGI-003), which is in Phase III clinical trials for the treatment of diarrhea-predominant irritable bowel syndrome (IBS-D). Results showed that the gastrointestinally active R-isomer, arverapamil, contained in Rezular can be administered to humans without exposing them to clinically relevant levels of the S-isomer, the form of verapamil which is most potent on cardiac and vascular tissue. They also showed that under both fed and fasting conditions, both the Cmax and AUC of the R-isomer after Rezular administration were less than those seen after administration of racemic verapamil. That indicates patients taking clinically relevant doses of Rezular will be exposed to lower systemic levels of the R-isomer compared to currently approved forms of racemic verapamil, the company said.
• Algeta ASA, of Oslo, Norway, said it soon will begin clinical development of Alpharadin in hormone-refractory prostate cancer patients. It filed an investigational new drug application with the FDA in December, and it has been cleared without any objections. An initial Phase I pharmacokinetics, biodistribution and dosimetry study with in HRPC patients with skeletal metastases will be conducted at the Memorial Sloan-Kettering Cancer Center in New York.
• Antisoma plc, of London, has begun a two-part Phase I clinical trial of drug candidate AS1409 in patients with renal cancer and melanoma. In the first part, successive cohorts of patients will receive increasing doses of AS1409 until a maximum-tolerated dose is identified. The second part of the trial will evaluate the safety and activity of that dose in about 20 more patients. Final results are expected in 2009. AS1409 is a genetically engineered fusion protein, which combines the antitumor cytokine IL-12 with a tumor-targeting antibody.
• Bionovo Inc., of Emeryville, Calif., said that results of an on-going Phase I/II trial of its breast cancer drug candidate, BZL101, showed higher doses were well tolerated. As a result, the company will be extending the dose escalation portion of the study longer than originally planned. BZL101 causes energy collapse in cancer cells by inhibiting glycolysis, which leads to DNA damage and cell death in cancer cells while normal cells remain unharmed.